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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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Following the release of PhRMA’s Special 301 Report urging the Office of the US Trade Representative to better protect American pharma companies’ intellectual property in foreign countries, BIO has released its own report this week, with an eye toward compulsory licensing and regulatory data protection.

Similar to PhRMA, BIO singles out Malaysia as a “Priority Foreign Country” following the issuance of a compulsory license in 2017 to make generic versions of Gilead’s hepatitis C treatment Sovaldi (sofosbuvir). A compulsory license allows a patented product to be produced without the consent of the patent owner.

“The use of compulsory licensing in Malaysia has far-reaching ramifications for the biopharmaceutical industry as other governments, such as Chile and Colombia are considering similar policies that would provide broad discretion to issue compulsory license,” BIO said.

Similarly, in Russia, BIO notes that multiple local firms are attempting to use compulsory licenses to produce generic versions of oncology drugs. “This raises serious concerns about the ability of innovators to meaningfully enforce patents in Russia and will discourage investors and innovators from bringing products into the market,” BIO added.

The threat of compulsory licensing in India was also highlighted by BIO, particularly as India allows for such licensing in some circumstances when the patented products are not manufactured in India.
Doctors Without Borders, however, has backed the right of certain countries to use compulsory licenses, explaining that they are “legal measures allowed under international trade rules to improve access to medicines.”

“Global trade policies give countries the right to act in the face of public health needs—they should be encouraged, not punished, for using these safeguards as they are meant to be used,” MSF said last year.

Regulatory Data Protection, Pricing and Other Concerns

In addition to compulsory licenses, BIO notes instances when countries fail to protect innovators’ data submitted to regulatory authorities when demonstrating the safety and efficacy of a medicine.

For instance, in India, the absence of regulatory data protection is a “significant problem” for BIO members because India’s drug regulatory agency approves generic drug applications based on an abbreviated submission that relies on the innovator’s safety and efficacy data. “This creates an unfair commercial advantage for Indian generic companies,” BIO explained.

Thailand was also highlighted for not using a formal system to prevent regulatory approval of generic versions of pharmaceuticals that are still covered by a valid patent.

In China, however, BIO raises concerns about a lack of transparency. For instance, in 2017, China’s National Medical Products Administration (NMPA) finalized a policy that provides accelerated review and approval to eligible drugs for applications that meet “urgent and unmet medical needs.”

“However, to date, China has not provided a definition for ‘urgent and unmet medical needs.’ Furthermore, BIO is concerned that generic drug applications may be granted priority review and approval by NMPA in cases where another party holds a valid patent.”

And while China did join the International Council for Harmonisation in 2017, Chinese manufacturers that only export their products are not subject to regulatory oversight or review, BIO said.

In Korea, BIO raises issues with the country’s “extreme” pharmacological data requirement, which “creates unfair, discriminatory obstacles for innovative biopharmaceutical companies. Moreover, almost all other countries’ patent offices do not require that amount of pharmacological data in the original application, or those offices allow submission of such data during patent prosecution.”

In Turkey, BIO criticizes the requirement by the Ministry of Health to perform Good Manufacturing Practices (GMP) inspection at every pharmaceutical production facility.

“While the Ministry of Health does allow for GMP certificates from other competent authorities, that acceptance is conditioned on other countries recognizing Turkish GMP certification. Nonetheless, with Turkey’s recent accession to PIC/S (Pharmaceutical Inspection Convention and Cooperation Scheme), which dictates international GMP standards, Turkey should begin to recognize GMP certificates issued by any of the current 52 PIC/S members. This positive development and further agreements with countries are expected to overcome the GMP hurdle and improve regulatory timelines,” BIO said.

“The methodology used by the Government of Japan in its HTA pilot, on which the HTA system will be based, was not developed in a transparent process and deviates from standard methodologies aligned with the latest available science,” BIO said.

Efforts to create a supplementary protection certificate (SPC) manufacturing waiver in the EU were also criticized by BIO, as they were also previously criticized by the European Federation of Pharmaceutical Industries and Associations.

Under the proposal, generic and biosimilar makers would be able to manufacture products protected by an SPC for export to non-EU countries where market protection for those products have either expired or never existed during the final six months of the SPC. The proposal would also allow for the stockpiling of generic and biosimilars intended for the EU market during those six months to promote faster market entry.